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Disease Management - Top 30 Publications

Interstitial lung disease points to consider for clinical trials in systemic sclerosis.

Interstitial lung disease causes major morbidity and mortality in patients with systemic sclerosis (SSc-ILD). Large randomized clinical trials in SSc-ILD have provided important information regarding the feasibility, reliability and validity of outcome measures. Forced vital capacity percentage predicted should be considered as a primary outcome measure, with inclusion of appropriate radiological and patient-reported measures. We provide practical recommendations for trial design in SSc-ILD.

Assessment of skin involvement in systemic sclerosis.

Skin involvement in SSc is an important marker of disease activity, severity and prognosis, making the assessment of skin a key issue in SSc clinical research. We reviewed the published data assessing skin involvement in clinical trials and summarized the major conclusions important in SSc clinical research. A systematic literature review identified randomized controlled trials using skin outcomes in SSc. Analysis examined the validity of the different skin measures based on literature findings. Twenty-two randomized controlled trials were found. The average study duration was 10.2 (s.d. 4.5) months, mean (s.d.) sample size 32.4 (32.6) and 26.7 (27.8) in intervention and control arms, respectively. The 17-site modified Rodnan skin score is a fully validated primary outcome measure in diffuse cutaneous SSc. Skin histology seems to be an appropriate method for evaluation of skin thickness. These findings have important implications for clinical trial design targeting skin involvement in SSc.

Points to consider in renal involvement in systemic sclerosis.

This article discusses points to consider when undertaking a clinical trial to test therapy for renal involvement in SSc, not including scleroderma renal crisis. Double-blind, randomized controlled trials vs placebo or standard background therapy should be strongly considered. Inclusion criteria should consider a pre-specified range of renal functions or stratification of renal function. Gender and age limitations are probably not necessary. Concomitant medications including vasodilators, immunosuppressants and endothelin receptor antagonists and confounding illnesses such as diabetes, kidney stones, hypertension and heart failure need to be considered. A measure of renal function should be strongly considered, while time to dialysis, mortality, prevention of scleroderma renal crisis and progression of renal disease can also be considered, although they remain to be validated. Detailed, pre-planned analysis should be strongly considered and should include accounting for missing data.

Points to consider for skin ulcers in systemic sclerosis.

This article discusses points to consider when undertaking a clinical trial to test therapy for skin ulcers in SSc. A validated definition of skin ulcers should be used if available. Defining a uniform SSc patient population, including consideration of disease duration, history of digital ulcers and capillaroscopic patterns, is important. Excluding confounding factors such as infection, calcinosis and trauma should be strongly considered, or at least accounted for, in defining patients. Outcome measures such as time to healing, prevention of new ulcers, function, pain and objective measures such as US, laser Doppler and thermography can be considered as outcome measures, although their validation has not yet been achieved and efforts may be needed to validate them before use. Likewise, biomarkers should be considered or consideration should be given to storing serum, plasma or cells for possible future analysis. A pre-planned analysis is important and should include consideration of missing data.

Points to consider when doing a trial primarily involving the heart.

Cardiac involvement contributes to the severity of SSc and should carefully be investigated and managed in SSc patients. Although it is commonly sub-clinical, once symptomatic it has a poor prognosis. Several complementary tools (circulating biomarkers, electrocardiography, echocardiography, scintigraphy or MRI) allow the assessment of all the various cardiac structures (endocardium, myocardium and pericardium) and heart function. Treatment remains empirical but cardiac trials in SSc can add data to the treatment of this complication.

Pulmonary hypertension related to systemic sclerosis: points to consider for clinical trials.

There are proven successful approaches to clinical trial design in pulmonary arterial hypertension (PAH), which in turn have led to the licensing of a number of effective therapies. SSc has been included in trials of World Health Organization Group 1 PAH but has been under-represented. Responses in outcomes as diverse as exercise capacity, quality of life, durability of drug effect and survival have been reduced in comparison with those seen in idiopathic PAH. The PAH community has achieved international and interdisciplinary consensus guidelines for future studies. We consider the diverse outcome measures used in trials in the context of the complexities of scleroderma. An argument is advanced in favour of future trials focused exclusively on SSc but with adaptations of the core outcome measures and trial design templates applicable to more general studies of PAH.

Muscle involvement in systemic sclerosis: points to consider in clinical trials.

SSc is clinically and pathogenetically heterogeneous. Consensus standards for trial design and outcome measures are needed. International experts experienced in SSc clinical trial design and a researcher experienced in systematic literature review screened the PubMed and Cochrane Central Register of Controlled Trials in order to develop points to consider when planning a clinical trial for muscle involvement in SSc. The experts conclude that SSc-associated muscle involvement is heterogeneous and lacks a universally accepted gold-standard for measuring therapeutic response. Although outcome studies are currently limited by the inability to clearly distinguish active, reversible muscle inflammation from irreversible muscle damage and extramuscular organ involvement, strong consideration should be given to enrolling patients with a myopathy that features several elements of likely reversibility such as muscle weakness, biopsy-proven active inflammation, an MRI indicating muscle inflammation and a baseline serum creatinine kinase above three times the upper limit of normal to prevent floor effect. Randomized controlled trials are preferred, with a duration of at least 24 weeks. Outcome measures should include a combination of elements that are likely to be reversible, such as muscle weakness, biopsy-proven active inflammation, creatinine kinase/aldolase and a quality of life questionnaire. The individual measurements might require a short pre-study for further validation. A biological sample repository is recommended.

Points to consider for clinical trials of the gastrointestinal tract in systemic sclerosis.

The pathogenesis of gastrointestinal tract involvement in SSc is not fully understood. However, gastrointestinal signs and symptoms are very common. Trials to test therapies, with rare exceptions, should be double-blind, randomized trials with either active therapy or placebo as comparators. Trial duration will vary dependent on the anticipated therapy and should usually be 6-24 weeks long, although some motility trials may need to be 52 weeks. As in any well-controlled trial, inclusion and exclusion criteria should encourage relatively uniform patients with sufficiently active disease to discern response, importantly considering disease duration. Previous therapy, co-morbid conditions, potentially confounding and/or concomitant therapy should be considered. Outcome measures should include both objective/semi-objective and subjective measures, although validated measures are not frequent and design needs to consider using only validated measures. Unvalidated measures can be included to validate them for future use. A full analysis plan should be completed before study commencement, including the method to account for missing data.

Ischemic Stroke: Advances in Diagnosis and Management.

Acute ischemic stroke carries the risk of morbidity and mortality. Since the advent of intravenous thrombolysis, there have been improvements in stroke care and functional outcomes. Studies of populations once excluded from thrombolysis have begun to elucidate candidates who might benefit and thus should be engaged in the process of shared decision-making. Imaging is evolving to better target the ischemic penumbra salvageable with prompt reperfusion. Availability and use of computed tomography angiography identifies large-vessel occlusions, and new-generation endovascular therapy devices are improving outcomes in these patients. With this progress in stroke treatment, risk stratification tools and shared decision-making are fundamental.

Mesenteric Ischemia: A Deadly Miss.

Mesenteric ischemia has 4 etiologies: arterial embolus, arterial thrombosis, venous thrombosis, and nonocclusive. No history or physical examination finding can definitively diagnose the condition. A wide variety of presentations occur. Pain out of proportion and gut emptying may occur early, with minimal tenderness. Once transmural infarction occurs, peritoneal findings and tenderness to palpation may occur. Physicians must be suspicious of pain out of proportion and scrutinize risk factors. Computed tomography angiography is the best imaging modality. Treatment requires surgery and interventional radiology consultation, intravenous antibiotics and fluids, and anticoagulation. The physician at the bedside is the best diagnostic tool.

Spontaneous Intracerebral Hemorrhage.

Although commonly arising from poorly controlled hypertension, spontaneous intracerebral hemorrhage may occur secondary to several other etiologies. Clinical presentation to the emergency department ranges from headache with vomiting to coma. In addition to managing the ABCs, the crux of emergency management lies in stopping hematoma expansion and other complications to prevent clinical deterioration. This may be achieved primarily through anticoagulation reversal, blood pressure, empiric management of intracranial pressure, and early neurosurgical consultation for posterior fossa hemorrhage. Patients must be admitted to intensive care. The effects of intracerebral hemorrhage are potentially devastating with very poor prognoses for functional outcome and mortality.

Penetrating Vascular Injury: Diagnosis and Management Updates.

Penetrating vascular injury is becoming increasingly common in the United States and abroad. Much of the current research and treatment is derived from wartime and translation to the civilian sector has been lacking. Penetrating vascular injury can be classified as extremity, junctional, or noncompressible. Diagnosis can be obvious but at other times subtle and difficult to diagnose. Although there are numerous modalities, computed tomography angiography is the diagnostic study of choice. It is hoped that care will be improved by using an algorithmic approach integrating experience from military and civilian research.

MANAGEMENT OF ENDOCRINE DISEASE: Flushing: current concepts.

Flushing can be defined as a sensation of warmth accompanied by erythema that most commonly is seen on the face and which occurs in episodic attacks. Such a problem can be clinically problematic, since many conditions and drugs can be related to flushing, and while often there appears to be no underlying organic disease, it is important to exclude disorders since they may be life-threatening conditions.

Resource-stratified implementation of a community-based breast cancer management programme in Peru.

Breast cancer incidence and mortality rates continue to rise in Peru, with related deaths projected to increase from 1208 in 2012, to 2054 in 2030. Despite improvements in national cancer control plans, various barriers to positive breast cancer outcomes remain. Multiorganisational stakeholder collaboration is needed for the development of functional, sustainable early diagnosis, treatment and supportive care programmes with the potential to achieve measurable outcomes. In 2011, PATH, the Peruvian Ministry of Health, the National Cancer Institute in Lima, and the Regional Cancer Institute in Trujillo collaborated to establish the Community-based Program for Breast Health, the aim of which was to improve breast health-care delivery in Peru. A four-step, resource-stratified implementation strategy was used to establish an effective community-based triage programme and a practical early diagnosis scheme within existing multilevel health-care infrastructure. The phased implementation model was initially developed by the Breast Cancer Initiative 2·5: a group of health and non-governmental organisations who collaborate to improve breast cancer outcomes. To date, the Community-based Program for Breast Health has successfully implemented steps 1, 2, and 3 of the Breast Cancer Initiative 2·5 model in Peru, with reports of increased awareness of breast cancer among women, improved capacity for early diagnosis among health workers, and the creation of stronger and more functional linkages between the primary levels (ie, local or community) and higher levels (ie, district, region, and national) of health care. The Community-based Program for Breast Health is a successful example of stakeholder and collaborator involvement-both internal and external to Peru-in the design and implementation of resource-appropriate interventions to increase breast health-care capacity in a middle-income Latin American country.

New Developments in Hypertrophic Cardiomyopathy.

Hypertrophic cardiomyopathy is the leading cause of sudden death in young individuals and an important cause of heart failure at any age. In this review we discuss advances in investigation and management of this heterogenous disease. Improved cardiac imaging has allowed us to detail many of the structural abnormalities whereas the use of new techniques, predominantly in cardiac magnetic resonance imaging, has given us a greater insight in to tissue architecture, mechanism of contractile abnormalities, and function. Risk stratification remains challenging because of the low event rate in clinical studies. Multicentre registries have improved risk stratification for sudden cardiac death and multiple models can be used to aid decision-making for implantable defibrillator therapy. We discuss the current state of nonsurgical septal reduction therapy and results of multicentre registries. New approaches to septal reduction therapy including refinement of alcohol ablation and noncoronary interventions such as radiofrequency ablation of the septum show great promise. Surgical myectomy remains a major part of treatment; a greater recognition of abnormalities of the mitral valve apparatus can allow improved surgical options. Myocardial perfusion abnormalities are known to predict adverse outcome in hypertrophic cardiomyopathy and we discuss underlying mechanisms and relevance to management. The off-label use of currently licensed medicines such as ranolazine, perhexiline, calcium channel blockers, and renin-angiotensin system antagonists are discussed. A novel approach to medical treatment of the underlying sarcomeric disorder has been investigated and shows great potential.

Clinical Progress in the Management of Tetralogy of Fallot in the Dominican Republic: A Case Series.

Definitive surgical interventions for Dominican children with congenital heart disease, like those of other low- and middle-income countries, have been historically limited.

Perioperative Pain Management for Upper Extremity Surgery.

Upper extremity surgeons are currently faced with a daunting array of anesthesia techniques, ranging from traditional general anesthesia to wide-awake surgery, during which patients can watch their surgeons operate in the morning and return to work as soon as that afternoon. This range of options means that surgeons must consider patient-related factors such as disease process and relevant comorbidities, as well as surgery-related factors such as anatomic location, complexity, length of procedure, and postoperative pain expectations. In general, the least invasive technique is favored, but each patient must be considered individually to ensure the best anesthesia choice.

Perioperative Pain Management in Pediatric Spine Surgery.

Pain management after spinal deformity correction surgery for scoliosis in the pediatric population can be difficult. Deformity correction with posterior spinal fusion causes significant tissue trauma. Historically, pain control has been achieved with intravenous opiates. Opiates provide excellent analgesic effect; however, they have serious consequences when used alone. In adult total joint arthroplasty, multimodal pain control has become an increasingly common method to achieve pain control without these sequelae. Recently, the same techniques have been studied in pediatric spinal deformity correction surgery. This article outlines the state of pain management in pediatric spine patients.

Pediatric Perioperative Pain Management.

Effective perioperative pain control in pediatric patients undergoing orthopedic surgery remains a challenge. Developing a successful pain control regimen begins preoperatively with assessment of the patient and discussion with the patient and family regarding expectations. Perioperative pain control regimens are customized based on the type of surgery, patient characteristics, and anticipated severity and duration of the postoperative pain. Recent study focuses on multimodal strategies and regional anesthesia options, allowing for decreased opioid use. This article provides an evidence-based overview of preoperative, intraoperative, and postoperative pain control for the pediatric orthopedic patient.

The Importance of Optimizing Acute Pain in the Orthopedic Trauma Patient.

Postoperative pain control is a highly studied topic because of its significant effect on costs, hospital course, and, most importantly, patient satisfaction. Opioid use has been the "status quo" of postoperative pain management but prolongs hospital stays and increases complications. Optimizing acute pain management in patients with orthopedic trauma is important and can translate into significant positive physiologic and financial outcomes. Although multiple viable examples of optimizing acute pain management in the literature demonstrate outcome improvements, implementation has not been widespread. Significant outcome success will depend more on systemwide implementation than a specific regimen for postoperative pain control.

Perioperative Pain Management in Hip and Knee Arthroplasty.

Total hip and knee arthroplasty is associated with significant perioperative pain, which can adversely affect recovery by increasing risk of complications, length of stay, and cost. Historically, opioids were the mainstay of perioperative pain control. However, opioids are associated with significant downsides. Preemptive use of a multimodal pain management approach has become the standard of care to manage pain after hip and knee arthroplasty. Multimodal pain management uses oral medicines, peripheral nerve blocks, intra-articular injections, and other tools to reduce the need for opioids. Use of a multimodal approach promises to decrease complications, improve outcomes, and increase patient satisfaction after hip and knee arthroplasty.

Perioperative Pain Management and Anesthesia: A Critical Component to Rapid Recovery Total Joint Arthroplasty.

Multimodal pain management has become the standard of care following total hip and knee replacement. The advantages include decreasing opioid consumption and its associated side effects, facilitating earlier mobilization, and faster return to function. An effective rapid recovery protocol includes the use of multiple different types of medications targeting each area of the pain pathway, preemptive analgesia, regional nerve blockade, and local infiltration analgesia.

Usefulness of Balloon Aortic Valvuloplasty in the Management of Patients With Aortic Stenosis.

We aim to evaluate the contemporary role and outcomes of balloon aortic valvuloplasty (BAV), based on physician intent, for the management of severe aortic stenosis. This is a prospective, 2-center study of 100 consecutive high-risk patients with severe aortic stenosis who underwent BAV. Before BAV, physicians assigned intent as (1) bridge to decision (BTD); (2) therapeutic bridge to planned therapy; or (3) palliation. Patients in the BTD arm underwent clinical assessment at 30 days to determine eligibility for definitive valve therapy. All patients were followed up to 1 year, with outcomes measured including procedural complications, Kansas City Cardiomyopathy Questionnaires scores, 30-day and 1-year mortality, and definitive valve therapy. Enrolled patients had a mean age of 80.6 (±9.6) years, Society of Thoracic Surgeons predicted risk of mortality of 11.4% (±7.1%), and 91 (91.0%) patients had class III or IV New York Heart Association congestive heart failure. Intent in the 100 study patients was 76 BTD; 20 therapeutic bridge to planned therapy; and 4 palliation. Thirty-day mortality for all patients was 6 of 100 (6.0%), and 1-year mortality for all patients who received definitive valve therapy was 6 of 54 (11.1%). For patients surviving to 30 days, adjusted (by Society of Thoracic Surgeons predicted risk of mortality) Kansas City Cardiomyopathy Questionnaires scores were significantly improved from baseline for all patients and BTD patients. In conclusion, as a bridge to decision and treatment tool, BAV appears to have a valuable role in properly selecting and improving patients to undergo definitive valve replacement.

Vitamin D supplementation to palliative cancer patients shows positive effects on pain and infections-Results from a matched case-control study.

We previously showed an association between low vitamin D levels and high opioid doses to alleviate pain in palliative cancer patients. The aim of this case-controlled study was to investigate if vitamin D supplementation could improve pain management, quality of life (QoL) and decrease infections in palliative cancer patients.

Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The SUMMIT Randomized Clinical Trial.

Primary care offers an important and underutilized setting to deliver treatment for opioid and/or alcohol use disorders (OAUD). Collaborative care (CC) is effective but has not been tested for OAUD.

Cost-Effectiveness of Multidisciplinary Management Program and Exercise Training Program in Heart Failure.

Heart failure causes significant health and financial burdens for patients and society. Multidisciplinary management program (MMP) and exercise training program (ETP) have been reported as cost-effective in improving health outcomes, yet no study has compared the 2 programs. We constructed a Markov model to simulate life year (LY) gained and total costs in usual care (UC), MMP, and ETP. The probability of transitions between states and healthcare costs were extracted from previous literature. We calculated the incremental cost-effectiveness ratio (ICER) over a 10-year horizon. Model robustness was assessed through 1-way and probabilistic sensitivity analyses. The expected LY for patients treated with UC, MMP, and ETP was 7.6, 8.2, and 8.4 years, respectively. From a societal perspective, the expected cost of MMP was $20,695, slightly higher than the cost of UC ($20,092). The cost of ETP was much higher ($48,378) because of its high implementation expense and the wage loss it incurred. The ICER of MMP versus UC was $976 per LY gained, and the ICER of ETP versus MMP was $165,702 per LY gained. The results indicated that, under current cost-effectiveness threshold, MMP is cost-effective compared with UC, and ETP is not cost-effective compared with MMP. However, ETP is cost-effective compared with MMP from a healthcare payer's perspective.

Cerebral Amyloid Angiopathy: Diagnosis, Clinical Implications, and Management Strategies in Atrial Fibrillation.

With an aging population, clinicians are more frequently encountering patients with atrial fibrillation who are also at risk of intracerebral hemorrhage due to cerebral amyloid angiopathy, the result of β-amyloid deposition in cerebral vessels. Cerebral amyloid angiopathy is common among elderly patients, and is associated with an increased risk of intracerebral bleeding, especially with the use of anticoagulation. Despite this association, this entity is absent in current risk-benefit analysis models, which may result in underestimation of the chance of bleeding in the subset of patients with this disease. Determining the presence and burden of cerebral amyloid angiopathy is particularly important when planning to start or restart anticoagulation after an intracerebral hemorrhage. Given the lack of randomized trial data to guide management strategies, we discuss a heart-brain team approach that includes clinician-patient shared decision making for the use of pharmacologic and nonpharmacologic approaches to diminish stroke risk.

Comparison of efficacy of continuous epidural block and pulsed radiofrequency to the dorsal root ganglion for management of pain persisting beyond the acute phase of herpes zoster.

There is little evidence regarding the effectiveness of intervention methods in the treatment of zoster-related pain (ZAP) after the acute phase of zoster. Generally, if ZAP remains after more than 180 days from its onset, the likelihood of pain reduction is very low; this condition is considered as a "well established" post-herpetic neuralgia (PHN). Although the clinical efficacy of intrathecal steroid injection and spinal cord stimulation (SCS) for ZAP management has been reported, these interventions are not widely used due to inherent disadvantages. Continuous epidural block is widely used in clinical practice, and the effectiveness of pulsed radiofrequency (PRF) to the dorsal root ganglion (DRG) in the treatment of ZAP already has been reported.

International Olympic Committee consensus statement on pain management in elite athletes.

Pain is a common problem among elite athletes and is frequently associated with sport injury. Both pain and injury interfere with the performance of elite athletes. There are currently no evidence-based or consensus-based guidelines for the management of pain in elite athletes. Typically, pain management consists of the provision of analgesics, rest and physical therapy. More appropriately, a treatment strategy should address all contributors to pain including underlying pathophysiology, biomechanical abnormalities and psychosocial issues, and should employ therapies providing optimal benefit and minimal harm. To advance the development of a more standardised, evidence-informed approach to pain management in elite athletes, an IOC Consensus Group critically evaluated the current state of the science and practice of pain management in sport and prepared recommendations for a more unified approach to this important topic.

Comparison of Outcomes of Acute Coronary Syndrome in Patients ≥80 Years Versus Those <80 Years in Israel from 2000 to 2013.

Although patients ≥80 years old constitute the fastest-growing segment of the population and have a high prevalence of coronary artery disease, few data exist regarding the outcome of octogenarians with acute coronary syndrome (ACS). In a retrospective study based on data of 13,432 ACS patients who were enrolled in the ACS Israel Survey, we first evaluated the clinical outcome of 1,731 ACS patients ≥80 years (13%) compared with 11,701 ACS patients <80 years (87%) hospitalized during 2000 to 2013. Second, we evaluated the clinical outcome of patients ≥80 years hospitalized during the 2000 to 2006 ("early") period (n = 1,037) compared with those of the same age group of patients hospitalized during the 2008 to 2013 ("late") period (n = 694). Implementation of the ACS AHA/ACC/ESC therapeutic guidelines was lower in ACS patients ≥80 years compared with patients <80 years. Multivariate Cox regression analysis demonstrated a worse 1-year survival rate in the ACS patients ≥80 years compared with those <80 years. During the late period, patients ≥80 years were more frequently treated with guideline-recommended therapies compared with patients from the same age group who were hospitalized in the early period. Multivariate Cox regression analysis demonstrated a better 1-year survival rate of patients ≥80 years during the late period compared with the early period (hazard ratio 1.17, 95% confidence interval 1.15 to 1.61; p = 0.01). In addition, adverse outcome rates of ACS patients ≥80 years were significantly higher compared with those of patients <80 years. However, survival rates of ACS patients ≥80 years were improved over the 200 to 2013 period.